Q2 2021 Erytech Pharma SA Earnings Call
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Good day, and thank you for standing by.
Looking to the Aerotech business update and financial highlights for the second quarter of year 2021.
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After the presentation, there will be a question and answer session.
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I'd now like to hand, the conference over to your Speaker today, Julien Chief Executive Officer. Please go ahead.
Thank you Liz.
Good afternoon. Good morning, Borderlands. Thank you for joining us for our earnings call to discuss the highlights and financials for the fluids helpful. This year.
Everyone is well and safe today wherever you may be taking today's call.
Our business and financial update yesterday evening September 20, the press release and the first half earnings presentation can be found on the investor sections of our website.
Joining me here today on this call our Doctor Imam <unk>, our Chief Medical Officer with me here in Boston, and Eric Smith, Our Chief financial and Chief operating officer dialing in from from Neil.
And switching to slide two.
Before starting we'd.
We'd like to draw your attention to the disclaimer to remind you that today's calls it groups forward looking statements such as relating to the company's operations anticipated timelines and financials.
As you know they all involve risks and uncertainties that could cause actual timings and results to differ materially.
Now switching to slide three the agenda for the call I will as usual start with a short introduction and present the key business highlights of the year.
To date in.
And focusing on the more recent ones the ones that if Europe after our last call in May.
Martin will then provide an update on the status and the progress of our four clinical programs to date after which Erik will present, the financial results for the first half of the year. You will also summarize the expected milestones for the coming years before we then open up the lines for Q&A.
Both all three of us will be available to answer your questions afterwards.
Moving to slide four the introduction for anyone new to the company here is a brief overview of every day.
Are the leader in Red blood cell based cancer Therapeutics as Juno are.
Our focus is on targeting cancer cells altered amino acid metabolism, and increasingly important and exciting area of cancer therapy.
We in this area, we have late stage clinical programs mm phreatic cancer triple negative breast cancer and <unk>.
Acute lymphoblastic leukemia.
And as I noted at our last call the upcoming quarter. The fourth quarter is truly a key quarter for everything with some flex up some key inflection points for for the company.
Yes.
We have four clinical programs programs ongoing two of them potentially pivotal essentially supporting an application for regulatory approvals and for both of them.
<unk>.
Important news this quarter.
More on that in a minute.
Just to summarize that introduction, we are producing a product in a fully operational facilities one in Europe.
To serve the European market.
Princeton for the U S market and also in terms of shareholder base very balanced between Europe, and U S with a euronext and the NASDAQ listing with roughly 50.50 shareholder base.
And then the highlights for the year slide five.
Again it has been.
Critical steps forwards since our last call in or first half of the year to bring our REIT product area spas to patients in need and this both in Europe and.
United States and highlights I would like to mentioned.
<unk> with Tribeca, one of course, our phase III trial in second line pancreatic cancer.
The work towards the final readout is continuing in full continue in full force over the summer and is continuing.
Now the eyes are really on the results, which we continue to expect in the fourth quarter of this year.
So tribeca one is to our knowledge the largest clinical trial ongoing in second line metastatic pancreatic cancer and has the potential.
Excess full to lead to a treatment paradigm shift against this terrible disease.
This study was initiated.
Three years ago.
And so now we are indeed.
Fully.
The ice focused on top line results not that far away.
And the amount will tell more about this than our <unk>.
Second highlight is in acute lymphoblastic leukemia more in this specific in AML patients, who develop hypersensitivity to regulated asparaginase.
Progressing we had positive data presented at Ash. We then had the dialogue ongoing with the FDA met the pre BLA meeting in June.
Which in July we confirmed our intention to submit a BLA by yearend. This.
Obviously subject to successful completion of remaining test as discussed drilling the PB in anything.
Also in June a note that was in July we were pleased.
We then were granted fast track designation for the treatment of Elo and so now the teams are working indeed too.
The BLA submission before before the end of the year.
Third highlights.
Anthony I think answer but now first line.
Highlights from our ISG trial that is ongoing in Georgetown University. The trial completed its first dose of three patients already before our previous call.
Meantime, the second of those is fully enrolled and we are.
Are eagerly awaiting the final results on safety.
Everything continues to go.
Yes.
We have seen so far.
We should be able to do that determined the MTBE shortly.
And then <unk>.
Lastly on this slide the successful financing 30 million registered direct offering that was done in may.
Such prolonged our our cash weight into the second quarter, but also here I will leave.
Leave it to Eric who will provide more detail shortly.
On the next slide slide six Youll see all of this is summarized in an overview I will not repeat youll see the check marks.
A achievements over the past months of the year and then indeed, a concentration of milestones.
Q1s.
In the fourth quarter.
Phase III results and BLA submission.
But also significant in defining milestones in the coming 12 months or so.
I'll stop here and over three months to provide additional color and detail on our.
Our clinical programs and their expected milestones.
The floor is yours.
Thank you.
Good morning, Steve Good afternoon.
And provide a quick update on thank you.
I see.
Any indications please.
Thank you Patrick cancer Triple negative.
As an indication.
Starting with slide number eight.
You have seen this slide before this is Tim.
Slide.
Which is.
Yes, it does.
Combination with chemotherapy in second line advanced.
Sure.
The study is.
Our actual today puts us at.
500.
Yes.
Earnings at <unk>.
Thanks, David.
Patients were randomized to receive.
Seamless therapy with <unk>.
Any exercise.
Backbone chemotherapy with a menu of tool either.
Okay fine.
Or are there any consumer tech team.
As a.
The primary endpoint is survival.
We have only.
The secondary endpoints, particularly Q1 progression free survival.
And just to go through the assessment.
His objective at this point it is quite clear.
This is Phil.
Quality of life and safety.
This study operationally.
Actually executed in 11 countries in Europe.
Steve.
Yes.
Yes.
100 sites.
And speaking in this trial.
Accordingly.
Fisher Pascal Amen.
Sure.
<unk>.
Yes.
Right.
Yes.
The study plans into the statistical design.
The study is.
Yes.
To look at it.
Movement in overall survival with hazard ratio of points it until five in favor of <unk>.
Eddie.
Okay.
This is Scott.
Ultimately, it's about maintenance above it.
Of six months and so in looking at improvement from six to eight.
<unk> seen months.
In the active arm.
So this is our plan for this study so moving to slide.
Slide number nine.
Give you a quick highlights what we have done so far study completed enrollment in with last year.
Ended up with 500.
Until it's done.
We actually were very happy with the start to enrollment. This was a major achievement not only for the company but for.
For the patients who participated in the trial.
Fight the pandemic that hit all of us that in fact.
<unk> to 'twenty.
Which also just didn't have a major impact because of the enrollment or the quality of the patients participating in this trial.
And the study.
I didn't see or I think team met four times during the life of the strategy. So far the first three.
Things, where <unk> used the word.
No safety issues.
Last one was conducted last February of this year and this was our.
First on on the interim analysis for efficacy, but also <unk>.
Based on the recommendation of the strategy continues until final analysis.
We are expecting.
The Tri Ed.
In the first quarter of this year, we are all.
We are working day and night to make sure that we have the data cleaning and data results land.
As guidance to the market.
I also wanted to make sure that.
Confirming that continue to be blinded to the.
So.
And that is it.
And we need to.
<unk> of the trial.
Moving to slide 10 switching gears within the same indication.
This is.
Our investigator initiated phase one study in first line pancreatic cancer.
Bye.
In Georgetown.
At University. So this study is to assess the safety also Europe entity of <unk>.
<unk> in combination with well defined footprint.
In this setting.
Puts it is becoming increasingly popular.
Chemotherapy of choice in that setting and therefore.
Thats a good rationale for us too.
<unk> of our drug with.
Chemotherapy regimen.
And.
As far as I'm, sorry on the primary endpoint is <unk>.
Yeah.
Getting that critical amended phase two dose for future budget in that setting.
Studies started beginning of this year started with those cohorts of 75 units.
Yes.
And.
Actually a series of units per kilogram.
<unk>.
It's just that just a typo there.
So.
As you know the dose.
Which we are using in our indications with 100 units per kilogram. So we started with slightly lower.
And there was no DLT observed and therefore.
Syed.
In fact, it can lead to the second and final dose cohort, which is the 100.
Right.
If you look at that.
This cohort has already fully enrolled.
Thank for the last patient in that cohort.
Or any dose limiting toxicities.
Does that give us hopefully soon we'll be able to declare our recommended free.
Phase II dose, which hopefully will be the 100 units.
But you look at on.
Fixing these results again the confirmation.
But again.
And the first question.
Of this year.
So that covers.
I think indications they are moving.
Slide moving to slide 11.
We also had very.
And are the beginning of this month.
First of all the individual store.
I am in that deck with Davis was we are good.
We've been not lots of questions were addressed and physically key outcome of this would have been or is that number one.
Cancer continues.
<unk> continues to be unmet medical needs.
When you buy so far is the only approved drug in second line setting.
So there is certainly room for new treatments and improving in this.
In these patients.
So.
Moving to slide number 12, so switching gears now to our second indication, which is the triple negative breast cancer.
Another highly unmet medical needs.
So we are starting with a proof of concept Cheyenne.
Nearby our day in.
As you put the envision and <unk>.
And if the study is a small randomized drawn 65 patients at <unk>.
In total in first and second line setting.
To assess clinical.
Clinical activity of <unk> when added to Jim Carnival.
So far this trial is Europe on Israel.
And we have a student michie.
They miss the.
I should have used the <unk> cheap profile, so far and again no issues. Given this is again, our first combination and we did not do a phase one trial.
Sue.
We are expecting our interim data Michel slash interim data in the first half of.
2022.
Moving to slide 16, so this will be our next indication and ambitious for us and a very exciting opportunity for severity events.
Really is.
Yeah.
Addressing again another amendment to can mean, it's important for the patients who develop hypersensitivity reactions to it.
Genius, particularly big and eastern and southern unions, which is the standard.
In force do you think these patients.
<unk>.
And an indication is based on.
No fourth sponsored.
It was a phase II trial that was presented last year at Ash 2020, and in that dry and average around 55 patients in total.
Patients who have developed purposes, just your actions were switched to receive <unk>.
With that same backbone cumulus therapy, there'll be able to compete ended courses of.
She needs therapy, the trial showed that.
<unk> activity was maintained in that.
In most if not all of those patients with a very good safety profile.
Right.
More importantly.
The convenience of treatment.
<unk> is a drug that just given once every two weeks that provides also.
A better quality of life for particularly for the pediatric population.
Is this it really is a recap of our.
If confirmed our view of that.
We still have an ethylene medical need.
Issues, which represent about 15% to 20%.
This definition.
While there are two drugs approved how do we need which has.
Suffer longest damaged supply shortage of newly approved finance.
Ishares.
Yes.
It is an important needs for a critical need to have an additional option for those patients and then.
For the convenience of treatment.
We ended up with two administrations per month as compared to 15 patients.
And you can imagine the impact of this number of administration, particularly if you have one year or two or three years.
So it's certainly affected that needs to pick one SEC.
The positive news for us so far but we have made.
The FDA.
Lost showing three months ago is our deepening anything and soon after we have been granted a fast track.
And with Takeda.
For us, it's becoming very important.
It takes us in our continuous dialogue with the FDA.
That's really the whole value of.
Designation.
We have guided before that we will have we intend to have our submission expected in.
In the fourth quarter.
And this will be contingent on our successful completion of was that a meeting.
Activities.
So with this I will just fill that appear and then.
I'll hand.
And over to Eddie Gray, our Chief financial and operations Officer, who will provide us with the financial updates and the news flow so over to you Eric.
Yes.
Thank you. Thank you very much Ivan good morning, everyone.
We're now moving to <unk>.
15.
Slide deck.
Reviewing the financial highlights for the first half of this year and it was talking with P&L inflammation.
Yeah.
As you can see the net flows for the first half of 'twenty one.
8 million Euro.
And thats down $7 million bonus 20% year over year.
With a $10.0 million decrease -18% in operating loss.
There are $6.
The $7.0 million Europe increase in financial income.
The $10.0 million euros decrease in operating loss was attributable.
Attributable to the $11.0 million decrease in preclinical and clinical development expenses of course, thats concurrent with the completion of patient enrollment in the competition phase II trial in pancreatic cancer Coca Cola.
Yes.
So there was 3 million Europe decrease in G&A expenses.
Zero 4 million Europe increase in other income mostly related to R&D tax credits.
The <unk> 6 million increase in financial results was mostly related to foreign currency gains on the U S dollar.
And now we're moving to the next slide number 16 will comment on cash.
As of June 30, 'twenty, one I would think as cash and cash equivalents totaling $46.
So we have made in euro.
Which is approximately $54 million.
And that's compared with $48.0 million Euro.
Principally $58.0 million on December 31, last year, and $41.0 million neuro on March 31 this year.
That's a $5.0 million increase in cash position during the first half of 'twenty, one and that was the result of it.
$32 nine win in Europe, net cash utilization, including $58.0 million in operating activities and build from $3 million in investing activities.
Also at $35.0 million euro generated in financing activities and thats, including.
$8 million replacement in the U S foods company's at the market or ATM equity financing program.
Net proceeds of $10.0 million Euro.
Also the $30 million reduced direct offering for net proceeds of $31.0 million in Europe.
And the drawdown of two tranches under the convertible notes the <unk> program.
Financing agreements signed with us erosion.
Sure.
<unk> or $5 five.
$12.0 million in Europe.
And finally, we have the variation of the U S dollar against the Euro and that led to 0.7 million euro positive currency impacts.
Moving to the next slide 17 with a word on our most recent financing initiatives.
You remember that on April 29, this year, we announced a registered direct financing with several healthcare focused institutional and accredited investors with a patient of ABS is American depositary shares at $32.0 601 Euro.
Yes.
And also associated with a 75% warrant coverage with two Europe sort of exercise price of seven and seven.
Southern Europe and 50.
Sure.
This was just with the financing associated with the mine a test of tranches.
Quarter to date.
Standard Covenant categorized into Q2 next year Q2 2022.
This cash horizon could possibly be further extended to Q3 'twenty two.
The company further utilize vehicles agreements.
Of course, assuming current market price and of course subject to the regulatory limit of 20% dilution.
Finally.
Moving to the next slide 18.
To quickly summarize the upcoming milestones before the will stop the Q&A session.
That's of course, the top line results.
<unk> tried the Columba phase II trial of <unk> in pancreatic cancer and as explained by if you will in the month, we expect top line results.
Quite soon in Q4 'twenty one.
We also.
Before the end of the year of the potential BLA filing of aerospace.
That's for hypersensitive patients.
Those patients again looking forward to.
Potentially filing a BLA dossier before the end of the Europe.
Also we will have.
The disposition of the MTV the maximum tolerated dose in the respect the phase one trial in first line pancreatic cancer.
Also before the end of the year.
And then towards the first half of next year.
We look forward to the potential BLA filing for aerospace in second line pancreatic cancer. Following the subprime results upfront with tier one and also the initial data from the phase II trial in breast cancer.
Terence.
Ongoing trying to get some trial and thus also.
As expected in the first half of 'twenty two.
Yeah.
With that I would like to thank you already for your attention.
We'll now open the call for any questions you may have.
Again I will.
Repeating myself from the remaining if you would like to ask questions in French that Europe very welcome to do so.
No.
But there's some kits also demo quadruple still going to look you could have it for the or look at all of this is a difficult depleted pneumonia resolved with Europe.
A positive picture.
Or at least that's well over to you.
If you'd like to ask a question at this time. Please press. The Star then the number one key on your Touchtone telephone.
That is star then one if you'd like to ask a question.
Again that is star then one if you'd like to ask a question.
Again, Please press Star then one if you'd like to ask a question.
We have a question from Boris <unk> with Cowen.
Good morning can you hear me.
Yes, Boris good morning.
Good how are you.
Question that comes up frequently is how does the patient enrollment in your pivotal pancreatic cancer compared to the phase two study in terms of geography age or any other characteristics as.
As well as any kind of follow up there are differences.
Oh.
Just to remind to answer.
Good morning, guys.
Compared to the phase one.
The phase II trial.
The overall productivity.
Sure.
There are highly similar to what we have in terms of inclusion exclusion criteria.
The real difference here is.
We don't believe is going to have any impact.
<unk> phase II trial with a fringe on these studies.
This is Brian <unk>, our global try on in Europe, and United States.
So that is Diane.
Profit difference.
France remained.
Our highest enrolling country in the phase III trial.
Hi.
Yes.
<unk>.
With that in mind, we actually compare to the fish to try and if you remember this.
Most patients received quite clear enough to offer a theory of fault blocks in a first line so I haven't.
90% of our patient in the second language Jim.
Jim said, you've been with therapy in the phase III trial that we are expecting to have at Merck patient receiving some advocacy and the second line.
We're going to be 90%.
Fixed revenue in <unk>.
<unk>.
But that's what would be the difference.
We have.
So within ours.
It's actually the same view for.
Professor <unk>.
First our view, which is we don't believe the bankable and chemotherapy when make premium much of a difference in terms of the activity of <unk> in combination with <unk>.
Which is R M.
At choices.
But otherwise for assembly affirmed this thesis.
Is the same.
And that of course progression after first line therapy.
Many other inclusion exclusion criteria session at Athene.
Great well, thank you very much and we all look forward to the big data reveal thanks for taking my questions.
Thank you Boris.
And I'm not showing any further questions at this time.
Then if no further questions.
We must be very clear so I want to thank you all.
For Europe.
For your attention for your continued support.
As Boris said it is indeed.
Looking forward to the data.
In the next quarter to come so, we'll obviously keep you posted as always.
And in the meantime, we wish you a great day.
Great.
And in Europe.
Thank you all I care about.
This concludes today's conference call.
Thank you for participating you may now disconnect.
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